Polymer Chemist

I.                SCOPE OF POSITION

This is a full-time onsite, hands-on position for a lead Polymer Chemist located in Montclair, NJ. The incumbent will be responsible for internal laboratory activities including chemical synthesis and purification of polysaccharides as well as own the analytical methods performed internally and externally. This position will also support the tech transfer of Endomedix technology to an external Contract Development Manufacturing Organization (CDMO). The Polymer Chemist will collaborate with both internal and external scientists & vendors for successful completion of projects and ensure that all work is conducted in compliance with Endomedix’s policies, procedures, and quality system.

II       DUTIES AND RESPONSIBILITIES

·      Perform chemical synthesis of derivatized polysaccharides in Company labs using established SOP’s and work instructions.

·      Co-ordinate with other scientists & lab technicians for successful conduct of experiments.

·      Perform purification of processed polysacchardies as per SOP’s

·      Coordinate with external labs performing H-NMR and SEC-MALS analyses of starting materials and finished batches.

·      Analyze data from process control and external laboratories.

·      Maintain batch records for each processed batch

·      Perform or oversee routine instrument calibrations and material prep for lab operations

·      Assist in tech transfer from Endomedix laboratory to external CDMO

·      Assist in the development of the CDMO work plan and schedule

·      Analyze CDMO test batch results using data from SEC-MALS, SEC-RI, H-NMR, FTIR, titration, and UV.

·      Develop a plan to verify materials coming from the CDMO

·      Review CDMO process control data

·      Conduct batch testing including mechanical testing, titrations, SEM, and viscosity (rheometer)

·      Development of new analytical methods if required

·      Assist in the preparation of grant proposals and external reports

·      Follow standard operating procedures (SOPs) for established laboratory methods

·      Perform statistical analysis on batch records

·      Assist in presentations to regulatory authorities and investors.

III      SUPERVISORY RESPONSIBITIIES                Possible in the Future

IV      QUALIFICATIONS

         Technical

·      M.S or PhD in organic chemistry, polymer chemistry or material science

·      Hands-on Experience with polymer synthesis & scaling up reactions required – 3 + years industry experience; experience with polysaccharides preferred

·      Extensive hands-on experience with polymer characterization techniques including gel permeation chromatography / size exclusion chromatography (GPC / SEC), viscometry, and rheology is required

·      Demonstrated experience in solving tough problems in polymer chemistry & scale up.

·      Strong proficiency with organic chemistry laboratory techniques and safety protocols

·      Bench-scale wet chemistry and spectroscopy (NMR & FTIR) skills required

·      Prior professional laboratory/chemical synthesis work experience or the equivalent in an analytical or product development lab required

·      Prior experience with standard statistical analytical methods for decision making required

·      Willingness to travel between CDMO site (Possibly International) and Company location

·      Salary commensurate with experience

Other

·      Ability to work collaboratively with cross-functional teams, including engineers, scientists, and regulatory personnel

·      Excellent verbal and written communication skills

·      Strong problem-solving and critical thinking abilities

·      Experience with medical device development, quality control, and regulatory requirements is preferred

·      Understanding of design control and risk management processes for medical devices is preferred

·      Knowledge of current Good Laboratory Practices (§58) Quality Management Systems (§820), ISO 13485, and other FDA regulations is preferred

Compensation:

Stock Options available in addition to Salary.